Senior Manager overseeing regulatory asset management and project delivery in a global biopharma company. Leading cross-functional collaboration to ensure oversight and compliance with regulatory strategies.
Responsibilities
Partner with GRL and Regulatory Matrix Teams and Early/Medicine Development Teams.
Create and manage integrated regulatory plans.
Ensure the team is on track to deliver per the Regulatory strategy.
Collaborate across the R&D matrix for project management and submission oversight.
Facilitate submission delivery expectations.
Requirements
Degree in a biological, healthcare, or scientific discipline or extensive experience within the drug development environment.
Good understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
Strong project management expertise in the pharmaceutical industry or in a regulatory environment.
Good knowledge of Regulatory Affairs responsibilities from pre-IND through Post-Approval.
Experience with project management and resource management systems, tools, & reporting features.
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